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argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis
https://www.argenx.com/news/argenx-submits-biologics-license-application-us-food-and-drug-administration-subcutaneous
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SC efgartigimod (1000mg efgartigimod-PH20) for the treatment of generalized myasthenia gravis (gMG) in adult patients.
SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. ENHANZE facilitates the subcutaneous injection delivery of biologics that are typically administered via intravenous (IV) infusion.
“Our vision for the gMG program is to deliver the broadest treatment offering for people living with this debilitating, and often overlooked disease. Every individual experiences gMG differently, which is why we’re excited about the possibility of introducing multiple ways to meet the needs of patients, including with route of administration and dosing schedule,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “The submission of this BLA is the latest milestone in honoring our commitment to the gMG patient community. We look forward to working closely with the agency through the BLA review process and to potentially bringing forth another first-in-class option for gMG patients.”
The BLA submission package includes data from the Phase 3 ADAPT-SC study evaluating the noninferiority of the pharmacodynamic (PD) effect of SC efgartigimod as compared with intravenously administered VYVGART in adult patients with gMG. The majority of enrolled patients were positive for acetylcholine receptor (AChR) antibodies, but the trial also included patients where AChR antibodies were not detected.
ADAPT-SC met its primary endpoint (p< 0.0001) of total IgG reduction from baseline at day 29 demonstrating noninferiority of SC efgartigimod to VYVGART. Patients treated with SC efgartigimod achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with VYVGART. Results were consistent across the overall population, including those with AChR antibodies and patients where AChR antibodies were not detected. Further, 69.1% of patients treated with SC efgartigimod were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Responders are defined as having at least a two-point improvement on the MG-ADL score for at least four consecutive weeks. 65.5% of patients treated with SC efgartigimod were responders on the Quantitative Myasthenia Gravis (QMG) score. Responders are defined as having at least a three-point improvement on the QMG score for at least four consecutive weeks. Minimal symptom expression (MSE), a measure of symptom-free status, was achieved in 37% of SC efgartigimod-treated patients after one treatment cycle. Onset of effect was also consistent with the Phase 3 ADAPT study.
The safety profile for SC efgartigimod was consistent with the ADAPT study. It was generally well-tolerated; the most frequent adverse event being injection site reactions (ISRs), commonly observed with biologics administered subcutaneously. All ISRs were mild to moderate and resolved over time. After completing ADAPT-SC, 95% of participants entered ADAPT-SC+, a three-year open-label extension study evaluating the long-term safety and tolerability of SC efgartigimod.
Phase 3 ADAPT-SC Trial Design
The Phase 3 ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of SC efgartigimod (1000mg efgartigimod-PH20) as compared with VYVGART (10mg/kg) in patients with gMG. The pharmacodynamic effect as measured by percent change from baseline in total IgG levels at day 29, one week after the last dose of IV or SC efgartigimod, served as the primary endpoint in the ADAPT-SC trial. The correlation between total IgG reduction and clinical benefit in gMG was demonstrated in a Phase 2 trial and the Phase 3 ADAPT trial, which served as the basis for approval of VYVGART in the U.S., Japan and Europe. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed.
A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial and were treated. Inclusion criteria of the trial were the same as the Phase 3 ADAPT trial of VYVGART; enrolled patients had a confirmed gMG diagnosis and an MG-ADL total score of at least 5 with greater than 50% of the total score attributed to non-ocular symptoms, at screening and baseline. Patients were on a stable dose of at least one gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs, and were required to remain on that stable dose throughout the primary trial. Patients were eligible to enroll in ADAPT-SC regardless of antibody status, including patients with AChR antibodies (AChR-Ab+) and patients where AChR antibodies were not detected.
Patients were randomized in a 1:1 ratio to receive SC efgartigimod or IV efgartigimod for one treatment cycle consisting of four doses at weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle.
See the full Prescribing Information for VYVGART in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp.
IMPORTANT SAFETY INFORMATION FOR VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. PRESCRIBING INFORMATION)
What is VYVGART® (efgartigimod alfa-fcab)?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
What is the most important information I should know about VYVGART?
VYVGART may cause serious side effects, including:
Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions.
Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you:
Have a history of infection or you think you have an infection
Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.
Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.
These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
Please see the full Prescribing Information for VYVGART and talk to your doctor.
About Efgartigimod
Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
About VYVGART
VYVGART® (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months1, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population1.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
Media:
Kelsey Kirk
kkirk@argenx.com
Investors:
Beth DelGiacco
bdelgiacco@argenx.com
Looks like they are winding up to start another scam. Make sure you read the explanatory statement of today's filing, which all but states out loud that they can lie, cheat and steal in their inevitable future PRs because they are an "emerging growth company". Believe what they say. The games are about to begin.
-Fritz
Yes, technically speaking, not a whole lot of support here. IMHO.
Looks like we revisit the $30s before we see the $50s again.
The previous convertible price was in the $70s. This one is $56.
Now we know why it's been sinking. Another convertible.
Approaching oversold; it should hold here and, if it does, no worries, just a natural reset IMHO. If it drops any lower, then I'd reassess.
Any thoughts on the call after haveing a few days to digest?
Glad to help.
Chartwise the up trend is just about busted. It could still recover from here but if not there isn't much support below until we hit the 200 dma which is at about $40.
Re Antares royalties, she didn't break it down overtly but near the end of question time the CFO pointed out the effect of Antares bolted on to the core income stream. Wasn't much, maybe +5% if I recall correctly.
I doubt that we'll see any upgrades after this call. Two reasons:
a.) There were some optimistic comments about new partners but the CFO really deflated the conversation in response to a question about plans for growth and all she could point to was the share buybacks. (Sigh....)
b.) The primary analysts were absent, probably on vacation at their beach houses, leaving the matters to scrubs and interns. They can ask a question or two but they aren't allowed to press any buttons. LOL!
Agreed about risk/reward, though, so staying the course.
-Fritz
I do think this is a normal pullback and barring bad news it will bounce.
One worry is whether the acquisition was more of a cost burden than Helen anticipated. We'll know soon enough.
Good on both counts. LOL!
You have always had your finger on the royalty pulse and your predictions have been dead on. You don't see a problem there and that's that as far as I'm concerned. That's not to say that we are clear sailing. We are still integrating the acquisition and there might be unexpected cost burdens, for example. Still, I just think someone is liquidating their position for external reasons and traders are taking advantage. JMHO.
Yes, volume did pick up but I still am not ringing the alarm bells. On the 6 month daily chart this looks very normal and almost predictable in it's regularity. Look out though, if it crashes below that support at ~$44. Then we might have an issue.
Thanks for posting your thoughtful analysis. Stick around and chime in when you can.
Good luck!
-Fritz
Also, HALO has a history of dropping on good news, like the yesterday's Tecentriq progress report. That has often been the case for reasons I can't deduce.
Low volume so not terribly concerned, at least as I'm typing this. Maybe one group is exiting their position for other reasons? If it breaks $44 that would be notable, otherwise it's a pullback from the last run and it's fairly normal looking chartwise. Also, nothing going on in the options space. What's your take?
That is a big bet.
Still very quiet on the options front. This might be interpreted bullishly, as the new buyers from last week or two are not particularly concerned about the need for hedging their positions. Just a thought....
Best wishes for a speedy and complete recovery.
-Fritz
In retrospect, it was probably due to some re-balancing for the new quarter combined with the really small float.
Chart is looking a little over bought and would normally mean a pause or a pullback here, so if the buying continues we'll have more certainty that something is up. If it cools off at this point, as it would in normal circumstances, then that would tend to confirm Howeeme's hypothesis. AIMHO
My only disagreement with your comment is that the HALO bounce end of last week far outpaced the XBI by a wide margin. In fact HALO has just about recovered to it's previous highs but the XBI has a long way to go to get there. That's why I thought things were getting weird. Just sayin'.....
It does appear that something is up and I've noticed no notable hedging in the options market either, so, things that make you go "hmmm"...."
Thanks for the link to the Cedars Sinai study. Dipping the toes back into panreatic cancer.
Stay tuned.
400k shares traded in first 30 minutes and up another 2 bucks (~4%) over yesterday's high volume move (up ~7% yesterday) on no news.
Ok, now things are officially getting weird.
New 52 week high on decent volume (3 million shares).
That makes sense both in terms of the small float and the 52 week high provoking some selling. Thanks for the input.
I agree that HALO is not high on the acquisition list, but that could change if the new injection technology is not a bust.
Yes the fade today was not bullish either, but I'm not of the opinion that it's indicative of any negative trend. We closed flat on high volume, so that's not concerning to me. We were close to the 52 week high and failed to touch it by only about 4 cents. Interesting times, but summer will be a time when nothing definitive happens. Wake me up in September. LOL!
Definitely caught my attention. If you believe price follows volume today was significant. On the other hand it might have been some portfilio rebalancing, since last Friday was an options expiry day. Also, the price spiked early then faded, which is not a bullish sign. Also got near or touched a 52 week high, which will probably draw some interest. Overall, I'm not going to get too excited. I think we have to get through summer doldrums before the real breakout continues, if it does at all.
What's your take? Do you think there is something else going on?
Do you think that this will bleed over into HALO's agreements?
Good find, thanks for posting. In the last conference call HALO put up a chart that showed Janssen with an undisclosed phase 1 trail. I wonder if this is it or if it is yet another newer one?
Here's the link to the presentation earlier in the month:
https://s28.q4cdn.com/284259014/files/doc_financials/2022/q1/Q1_2022_Earnings_Presentation_DRAFT-v7_final-review.pdf
I wasn't concerned about the financing; it was prudent and even necessary. I was disheartened by the disclosure of the new bio-similar timing.
Yahoo is spurious. The difference may lie in the new tax liabilities, which, had they not been required, would have accounted for an additional $.10 per share if I heard correctly in today's call.
You nailed the royalties.
For comparison's sake here is a link to the PowerPoint on the financials from the last Q and Year End 2021 which was on 2.22.22.
https://s28.q4cdn.com/284259014/files/doc_financials/2021/q4/Q4-2021_Earnings_Presentation_-February_22_FINAL2.pdf
2023? That's a long wait to get back to where we were before all the financing hooha.
I'm leaving this post on the board so everyone can evaluate any future musings you might grace us with, and also the humor value.
Broke through resistance at about $43 or so. Next resistance at about $45 and $50 after that. Volume is low, so I'm not sure of the momentum and conviction. Overall better than lingering at those lower levels.